Comparing superabsorbent dressings for venous leg ulcers
A Prospective, Multicenter, Partially Assessor Blinded, Randomised, Open Label, Parallel, Comparative Clinical Trial to Evaluate the Exudate Management Performance of Cutimed Sorbion Product Range
This study is testing two different superabsorbent dressings to see which one works better for helping people with venous leg ulcers heal and stay dry.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BSN Medical GmbH Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Melle, Niedersachsten and 2 other locations) |
| Trial ID | NCT06300762 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the clinical performance of two commonly used CE-marked superabsorbent dressings in managing venous leg ulcers (VLUs). It focuses on assessing the absorption capacity of these dressings and their effectiveness in preventing skin maceration and leakage. Participants will be monitored for their wound healing progress while using the assigned dressing in routine care. The study will include individuals with VLUs that meet specific size and duration criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with venous leg ulcers that have been present for at least 4 weeks but not more than 1 year.
Not a fit: Patients with ulcers younger than 4 weeks or older than 1 year, or those with ulcers outside the specified size and depth criteria, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved wound care practices and better healing outcomes for patients with venous leg ulcers.
How similar studies have performed: Previous studies have shown promise in using advanced wound dressings for similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment 2. Participant is mentally and physically able to participate in this study 3. Men, women, diverse ≥ 18 years 4. Participant complies with study visit schedule 5. Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy) 6. Participant suffers from lower leg ulcer\* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following: 7. Ulcer is not younger than 4 weeks and not older than 1 year 8. Ulcer is ranging between 2 cm2 and 800 cm2 9. One side of the ulcer is not extending 40 cm 10. Depth of ulcer \< 2 cm 11. Ankle-brachial pressure index (ABPI) of \>0.8 and ≤1.3, measurement not older than 12 months \* Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study. Exclusion Criteria: 1. Participant already participates in this study with one ulcer (only one ulcer per participant is allowed) 2. Participant is expected not to be willing or able to follow the study outlines and requirements 3. Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS 4. Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids 5. Participant uses any medication that could potentially delay the wound healing ability 6. Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc. 7. Participant is pregnant or currently breastfeeding 8. Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone 8\. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and/or joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis
Where this trial is running
Melle, Niedersachsten and 2 other locations
- Niels Stensen Klinik, Christliches-Klinikum-Melle — Melle, Niedersachsten, Germany (Recruiting)
- Mid Yorkshire Teaching NHS Trust Pinderfields Hospital — Wakefield, West Yorkshire, United Kingdom (Recruiting)
- Northumbria Healthcare NHS Foundation Trust — Ashington, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Hardy Schweigel, PhD
- Email: hardy.schweigel@essity.com
- Phone: +491522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.